The Effect of Resistance Training on Sarcopenia in Older Heart Failure Patients

Kieu Nguyen Dang Phuong

Status: Enrolling

Conditions: Chronic Heart Failure; Sarcopenia in Elderly

Treatments: Other: Machine-based Resistance Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06785168

24590-DHYD

Details and patient eligibility

About

The goal of study is to evaluate the effects of an eight-week machine-based resistance training program on managing sarcopenia in older outpatients with chronic heart failure (HF) at Military Hospital 175.

Full description

The participants will be randomly assigned to two groups: One group received machine-based resistance training (MRT) at the hospital, while the other group received usual care (US). The outcomes will be measured in the participants after 8 weeks including handgrip strength, gait speed, performance on the five-times sit-to-stand test.

Enrollment: 146 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Aged ≥ 60 years old
• Meet the diagnostic criteria of 2019 AWGS2 sarcopenia, can be diagnosed once meeting (1) + (2) or (1) + (3) or (1) + (2) + (3): (1) Appendicular skeletal muscle mass (ASM): dual-energy X-ray absorptiometry (DXA) (male <7.0 kg/m², female <5.7 kg/m²). (2) Muscle strength: handgrip strength (male <28.0 kg, female <18.0 kg). (3) Physical performance: 6-meter walking speed <1.0 m/s.
• Meet the diagnostic criteria of heart failure following ESC 2021.
• Clearly understand the content and purpose of the study and sign the informed consent form.

Exclusion Criteria: There are contraindications for Exercise Testing in patients with stable heart failure according to ACSM 2022:

• Early stage after acute coronary syndrome (within the first 2 days)
• Unstable coronary artery disease
• Decompensated heart failure
• Acute venous thrombosis or recent arterial embolism (pulmonary or systemic)
• Acute myocarditis, pericarditis, endocarditis
• Aortic dissection of the valve
• Severe symptomatic aortic stenosis
• Acute systemic disease or fever
• Uncontrolled or life-threatening atrial or ventricular arrhythmias (including new-onset atrial fibrillation or flutter)
• Uncontrolled tachycardia (resting heart rate > 120 beats per minute)
• Third-degree AV block
• Uncontrolled diabetes
• Symptomatic orthostatic hypotension (> 20 mmHg)
• Gradually increasing fatigue during exercise or dyspnea at rest or with exertion within the past 3-5 days
• Significant myocardial ischemia at low workloads < 2 METs or 50W
• Relative contraindications according to ACSM 2022:
• Weight gain ≥ 1.8 kg in the past 1-3 days
• Simultaneous use of continuous or intermittent Dobutamine
• Decrease in blood pressure with exercise
• NYHA IV heart failure
• Complex ventricular arrhythmias at rest or with exertion
• Resting heart rate ≥ 100 bpm when lying down
• Comorbidities that limit exercise
• Severe obstructive hypertrophic cardiomyopathy
• Have participated in a cardiovascular rehabilitation program within the last 6 months
• Do not agree to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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146 participants in 2 patient groups

Usual Care Group (US)

No Intervention group

Description:

The participants will receive HF treatment as prescribed by cardiologists based on clinical guidelines. If participants have any additional medical conditions, their existing medications or treatments should continue. The prescribed medications should remain the same throughout the trial, with dosage adjustments only made if adverse events occur. The participants are also asked to maintain their usual physical activity, exercise routines, and dietary habits, without making changes outside of the study intervention. Researchers will contact incorrectly by phone weekly.

Machine-based Resistance Training Group

Other group

Description:

The participants will receive HF treatment as prescribed by cardiologists. If participants have any additional medical conditions, their existing medications or treatments should continue. They are also asked to maintain their usual physical activity, exercise routines, and dietary habits, without making changes outside of the study intervention. And they will train 3 nonconsecutive days/week during 8 weeks as follows: leg press and calf raise by Proxomed Compass 540 (Germany); leg curl, chest press, push up, seated row by HUR

Treatment:

Other: Machine-based Resistance Training